GastroparesisNCT00761254
Domperidone for Relief of Gastrointestinal Disorders
A study testing Domperidone in people with Gastroparesis and GERD, run by Carle Physician Group at 1 site in United States.
Trial summary
The purpose of this study is to make Domperidone available to patients with gastrointestinal disorders who have failed standard therapy and who might benefit from it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis, GERD, Esophagitis
- What is being tested?
- Domperidone
- Type of treatment
- Pill or oral medicine
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms, gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that is refractory to standard therapy
- subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.
Who cannot join
- history of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation, and Torsade de pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
- clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females.)
- clinically significant electrolyte disorders.
- gastrointestinal hemorrhage or obstruction.
- presence of a prolactinoma (prolactin-releasing pituitary tumor.)
- pregnant or breast feeding female.
- known allergy to Domperidone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carle Health Care Incorporated d/b/a Carle Physician Group
Urbana, Illinois, 61801
About this study
Official title: Oral Domperidone for Relief of Gastrointestinal Disorders in Patients Who Failed Standard Therapy
The purpose of this study is to make Domperidone available to patients with gastrointestinal disorders who have failed standard therapy and who might benefit from it.
Read the detailed description
Domperidone is the only medication that is a true prokinetic with a low percentage of side effects that is useful in the treatment of certain GI conditions, including gastroparesis and other motility disorders.
According to recent regulations, writing prescriptions for subject to obtain domperidone outside the United States has been determined to be illegal and the FDA has issued warnings against pharmacies compounding domperidone. The legal way of administering domperidone is by obtaining an Investigational New Drug Application.
This study is an effort to both follow federal regulations and provide the medication to subjects who would benefit from it where standard therapy has failed.
- Conditions
- Gastroparesis, GERD, Esophagitis, Dyspepsia, Chronic Idiopathic Constipation, Nausea
- Being tested
- Domperidone
- Keywords
- Domperidone, Gastroparesis
- Medical subject headings
- Gastroparesis, Gastroesophageal Reflux, Esophagitis, Dyspepsia, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomperidoneDrug
Also called Motilium
Initially, 10mg of oral Domperidone will be administered 2-4 times a day as needed. This dosage may be increased or decreased depending on how the subject responds to the drug.
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief for patients with gastrointestinal disorders who have failed standard therapy
Measured: As long as the subjects continue to take Domperidone.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2012 (estimated)
- Study completionSep 2012
Why it stopped: PI withdrew due to increased responsibilities in clinical department.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carle Physician Group
- Responsible party
- Sponsor
- Investigators
- Andrew Batey, M.D., Principal investigator, Carle Health Care Incorporated d/b/a Carle Physician GroupAnna Keck, PhD, Study director, Carle Foundation HospitalJames Dougherty, MD, Study director, Carle Foundation HospitalEugene Greenberg, MD, Principal investigator, Carle Physician GroupVicki Shah, PA, Principal investigator, Carle Physician Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761254
- Sponsor's protocol ID
- 08-153
- Status last verified
- Sep 2012
- First submitted
- 25 Sep 2008
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ahmad N, Keith-Ferris J, Gooden E, Abell T. Making a case for domperidone in the treatment of gastrointestinal motility disorders. Curr Opin Pharmacol. 2006 Dec;6(6):571-6. doi: 10.1016/j.coph.2006.07.004. Epub 2006 Sep 25.
PubMed 16997628Reddymasu SC, Soykan I, McCallum RW. Domperidone: review of pharmacology and clinical applications in gastroenterology. Am J Gastroenterol. 2007 Sep;102(9):2036-45. doi: 10.1111/j.1572-0241.2007.01255.x. Epub 2007 May 3.
PubMed 17488253Barone JA. Domperidone: a peripherally acting dopamine2-receptor antagonist. Ann Pharmacother. 1999 Apr;33(4):429-40. doi: 10.1345/aph.18003.
PubMed 10332535Champion MC, Hartnett M, Yen M. Domperidone, a new dopamine antagonist. CMAJ. 1986 Sep 1;135(5):457-61.
PubMed 3527396
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Domperidone for Relief of Gastrointestinal Disorders in Patients Who Failed Standard Therapy
- ClinicalTrials.gov ID
- NCT00761254
- Acronym / sponsor ID
- 08-153
- Conditions
- Gastroparesis, GERD, Esophagitis, Dyspepsia, Chronic Idiopathic Constipation, Nausea
- Keywords
- Domperidone, Gastroparesis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI withdrew due to increased responsibilities in clinical department.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Carle Physician Group
- Study start
- Aug 2008
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to make Domperidone available to patients with gastrointestinal disorders who have failed standard therapy and who might benefit from it.
Detailed description
Domperidone is the only medication that is a true prokinetic with a low percentage of side effects that is useful in the treatment of certain GI conditions, including gastroparesis and other motility disorders.
According to recent regulations, writing prescriptions for subject to obtain domperidone outside the United States has been determined to be illegal and the FDA has issued warnings against pharmacies compounding domperidone. The legal way of administering domperidone is by obtaining an Investigational New Drug Application.
This study is an effort to both follow federal regulations and provide the medication to subjects who would benefit from it where standard therapy has failed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms, gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that is refractory to standard therapy
- subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.
Key exclusion criteria (7 listed)
- history of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation, and Torsade de pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
- clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females.)
- clinically significant electrolyte disorders.
- gastrointestinal hemorrhage or obstruction.
- presence of a prolactinoma (prolactin-releasing pituitary tumor.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DomperidoneAlso: MotiliumInitially, 10mg of oral Domperidone will be administered 2-4 times a day as needed. This dosage may be increased or decreased depending on how the subject responds to the drug. | Drug | – |
Primary outcome
Relief for patients with gastrointestinal disorders who have failed standard therapy
Time frame: As long as the subjects continue to take Domperidone.
Results and safety
The study was stopped early (reason given: PI withdrew due to increased responsibilities in clinical department.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2012.
- Background: PubMed 16997628Ahmad N, Keith-Ferris J, Gooden E, Abell T. Making a case for domperidone in the treatment of gastrointestinal motility disorders. Curr Opin Pharmacol. 2006 Dec;6(6):571-6. doi: 10.1016/j.coph.2006.07.004. Epub 2006 Sep 25.
- Background: PubMed 17488253Reddymasu SC, Soykan I, McCallum RW. Domperidone: review of pharmacology and clinical applications in gastroenterology. Am J Gastroenterol. 2007 Sep;102(9):2036-45. doi: 10.1111/j.1572-0241.2007.01255.x. Epub 2007 May 3.
- Background: PubMed 10332535Barone JA. Domperidone: a peripherally acting dopamine2-receptor antagonist. Ann Pharmacother. 1999 Apr;33(4):429-40. doi: 10.1345/aph.18003.
- Background: PubMed 3527396Champion MC, Hartnett M, Yen M. Domperidone, a new dopamine antagonist. CMAJ. 1986 Sep 1;135(5):457-61.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Batey, M.D. principal investigator
Carle Health Care Incorporated d/b/a Carle Physician Group
Anna Keck, PhD study director
Carle Foundation Hospital
James Dougherty, MD study director
Carle Foundation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Domperidone in people with Gastroparesis and GERD, run by Carle Physician Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI withdrew due to increased responsibilities in clinical department.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief for patients with gastrointestinal disorders who have failed standard therapy (time frame: As long as the subjects continue to take Domperidone.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00761254, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2012.